Ergoline/PASSION PLUS 40/3 Smart Performance - PF

GUDID EJKP10000100003599A0

JK-Products GmbH

Ultraviolet tanning device
Primary Device IDEJKP10000100003599A0
NIH Device Record Keyb0082860-bf7c-400e-9d92-5dbf13903f7e
Commercial Distribution Discontinuation2019-09-08
Commercial Distribution StatusNot in Commercial Distribution
Brand NameErgoline/PASSION PLUS 40/3 Smart Performance - PF
Version Model NumberJK 103 / 40-3 AC
Company DUNS316232073
Company NameJK-Products GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEJKP10000100003599A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LEJBooth, Sun Tan

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-09-09
Device Publish Date2019-08-19

On-Brand Devices [Ergoline/PASSION PLUS 40/3 Smart Performance - PF]

EJKP100003599A0JK 103 / 40-3 AC
EJKP10000100003599A0JK 103 / 40-3 AC
EJKP100003935A0JK 103 / 40-3 AC

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